Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial (USRLD: Lupron Injection, 1 mg/0.2 mL).

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer. It will be manufactured at the company’s oncology injectable manufacturing facility at SEZ1, Ahmedabad (ALIDAC).

Leuprolide Acetate injection had annual sales of USD 69 million in the United States (IQVIA MAT Sept- 2025).

The group now has 427 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.